A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis

A Phase II Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects With Mild to Moderate Atopic Dermatitis

This study is composed of a two-arm, double-blind, randomized, placebo-controlled, Phase II study to evaluate the efficacy of AR100DP1 compared to placebo on AD lesion area(s) in subjects with mild to moderate AD.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis Atopic
• Intervention / Treatment: Drug: 0.5% AR100DP1; Other: Placebo

Detailed Description

Eligible subjects with mild to moderate AD will have 14 days of treatment with 0.5% AR100DP1 or placebo on all AD lesion area(s). At Screening Visit, all AD lesions will be measured and recorded in cm², and the investigator will identify one or multiple patches of AD lesions with an Investigator's Global Assessment (IGA) score of 1 to 3, and a maximum total treated area of 1,050 cm². For topical administration of IP, AR100DP1 will be applied on all AD lesion area(s) two times a day for 14 days. At subsequent visits, the lesion regions of all applied study IP will be traced, measured, and recorded. If any existing AD lesion expands or a new AD lesion with an IGA score of 1 to 3 is detected during the study period, the investigational product (IP) may continue to be applied, provided that the total treated area does not exceed 1.5 times the total AD lesion area defined on Day 1.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yeh B Wu; Phone Number: +886-3-573-3608; Email: ybw333@arjilbio.com

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 110
      • Recruiting
      • Taipei Medical University Hospital
      • Contact: Ming-Hsiu Lin; Phone Number: +886-2-2737-2181; Email: mailto:minghsiu@tmu.edu.tw
    • Taoyuan, Taiwan, Taiwan, 333
      • Not yet recruiting
      • Chang Gung Memorial Hospital-Linkou
      • Contact: Chun-Bing Chen; Phone Number: +886-3-3281200; Email: chunbing.chen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Dated and signed informed consent
2. Either gender, ≥ 18 years old (the legal age of consent majority is 18 years old in Taiwan)
3. Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)
4. Clinical diagnosis of AD with clinically consistent and stable disease status, defined as AD lesions with the Investigator's Global Assessment (IGA) score of 1(almost clear) to 3(moderate) for at least 4 weeks prior to Screening Visit, at the investigator's discretion
5. Not expected to require regular AD maintenance therapy during the study period, at the investigator's discretion
6. Have AD lesion area(s) with an IGA score of 1 to 3 at the Screening Visit and Day 1, with a maximum total treated area of 1,050 cm², as judged by the Investigator.
7. Have a pruritus NRS score of ≥ 2 for both the average itch and the worst itch in the past 24 hours, as assessed at Screening Visit and Day 1 prior to randomization
8. Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration

Exclusion Criteria:

1. Fluctuating or actively infected AD judged by the investigator

2. Have any AD lesion with an IGA score of 4 at the Screening Visit or Day 1, as judged by the Investigator

3. History of the following conditions, including irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases

4. Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator

5. Received systemic medication including immunosuppressant, phototherapy, or other therapy, which could affect AD within 4 weeks before Day 1

6. Received systemic antihistamine within 5 half-lives (see Appendix 1 for half-lives of common antihistamine) prior to Day 1 (except for permitted background medication, Fexofenadine)

7. Received systemic corticosteroid within 2 days or 5 half-lives, whichever is longer, prior to Day 1

8. Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD lesion area(s) within 1 week before Day 1

9. Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine)

10. Unwilling or unable to comply with the criteria in Life Style Guidelines (Section 5.3) during the study

11. History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1

12. Received any other investigational drug within 4 weeks prior to Day 1

13. Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to Day 1, including but not limited to clarithromycin, itraconazole, nefazodone, and atazanavir, evaluated by the investigator

14. Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before Day 1

15. Had surgery within 4 weeks prior to Day 1, or plan to have surgery during the study.

16. Known hypersensitivity to any of the components of the study drug

17. Active clinically serious infection or any known history of immunodeficiency, including human immunodeficiency virus (HIV) infection

18. Current uncontrolled asthma

19. Any of the following serum test abnormalities:

    • Total bilirubin > 1.5 × ULN
    • AST or ALT > 3.0 × ULN
    • Serum albumin < 2.5 g/dL
    • Creatinine > 1.5 × ULN
    • Any other ≥ Grade 2 (grading of NCI-CTCAE v6.0) laboratory abnormality at baseline (other than those listed above)

20. With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject

21. Female subject who is lactating or has positive urine pregnancy test at Screening and Day 1

22. Other conditions not suitable for participating in this study judged by the investigator

23. Plan to donate blood, sperm, or eggs from Screening Visit until Final Visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5% AR100DP1; AD subjects receive 0.5% AR100DP1	Drug: 0.5% AR100DP1; Investigational drug administered according to the protocol schedule.
Placebo Comparator: Placebo; AD subjects receive placebo	Other: Placebo; Visually identical placebo containing no active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of IGA to 0 or 1 at visit 4 after 14 days treatment	Proportion of subjects with the Investigator's Global Assessment (IGA) score of 0 or 1 at Visit 4 (Day 15).	From Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - the change of IGA	Proportion of subjects achieving the Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)	Evaluated at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)
Efficacy - the change of lesion area(s) (cm²)	Change from baseline (Visit 2) of lesion area(s) to Visit 3-6	Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change of pruritus NRS	Change from baseline (Visit 2) in pruritus NRS(Numerical Rating Scale) of itch level on lesion area(s) to Visit 3-6	Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change ≥ 2 points of reduction of pruritus NRS	Proportion of subjects having ≥ 2 points of reduction from baseline (Visit 2) in pruritus NRS for worst itch in the past 24 hours on lesion area(s) to Visit 3-6	Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change of signs of atopic dermatitis	Change from baseline (Visit 2) in signs of atopic dermatitis (erythema, edema/papulation, excoriation, and lichenification) with grading from 0(none) to 3(severe) on lesion area(s) to Visit 3-6	Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety- AE and SAE	Incidence of AE and SAE during Visit 2-6 and AE will be categorized by severity (toxicity grade) and relationship to the study intervention	Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - change of vital sign	Change from baseline (Visit 2) in vital signs to Visit 3-6	Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - abnormality in physical examination occurred	Abnormality in physical examination at Visit 2-6	Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - ECG result	Transition of ECG result from normal to abnormal findings from baseline (Visit 2) to Visit 3-6	Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - Lab parameters	Change from baseline (Visit 1) in laboratory parameters to Visit 3-6	Evaluated at Visit 1 (-14 to -1 Day), (Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - assessment of local tolerability	Proportion of subjects with scores of 0 and 1 in each symptom of assessment of local tolerability (erythema, edema, vesiculation, and excoriation) with grading from 0 (none) to 3 (severe) at Visit 2-6	Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)

Collaborators and Investigators

• Sponsor: Arjil Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Estimated): October 21, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: October 7, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 3, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: AR100DP1-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No